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| Sponsor: | Apex Bioscience |
|---|---|
| Information provided by: | Apex Bioscience |
| ClinicalTrials.gov Identifier: | NCT00021502 |
Purpose
To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist.
| Condition | Intervention | Phase |
|---|---|---|
|
Shock Systemic Inflammatory Response Syndrome |
Drug: pyridoxalated hemoglobin polyoxyethylene conjugate (PHP) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Multi-Center, Randomized, Placebo Controlled Study of PHP When Administered by Continuous Infusion in Patients With Shock Associated With Systemic Inflammatory Response Syndrome (SIRS) |
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2001 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
This Phase 3, randomized, placebo controlled, multi-center study is designed to evaluate the safety and efficacy of continuous IV infusion of PHP plus conventional vasopressor treatment, as compared to continuous IV infusion of Plasma-Lyte A plus conventional vasopressor, as a treatment for restoring hemodynamic stability in SIRS patients with shock. Conventional vasopressors include dopamine > 5 mcg/kg/min; or norepinephrine, phenylephrine or epinephrine at any dose.
The study consists of a Screening period, a Pre-Treatment period, and a 28-day Treatment period. Efficacy will be determined by evaluating objective clinical measures of mortality and organ function over the 28-day treatment period.
The safety and tolerability of PHP will be evaluated over the continuous 28 days using a number of measures including an evaluation of:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Determination of study eligibility will be made by the Investigator on the basis of the inclusion criteria listed below:
SIRS Inclusion Criteria
Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):
Shock Inclusion Criteria Patients with adequate fluid resuscitation (PCWP >/= 12mmHg) and with one or more conventional vasopressors (continuing up to the time of randomization) being used to treat hypotension (MBP < 60 mmHg or SBP < 90 mmHg). Patients cannot be entered if they have been in shock for more than 24 hours.
Contacts and Locations More Information
| Study ID Numbers: | APX-PHP 99-004 |
| Study First Received: | July 18, 2001 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00021502 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP) Systemic Inflammatory Response Syndrome (SIRS) Nitric oxide (NO) Shock |
|
Systemic Inflammatory Response Syndrome Disease Pathologic Processes |
Shock Syndrome Inflammation |
